FDA批准了GSK的Exdensur(GSK’s Exdensur),这是针对12岁以上病人严重哮喘的每年两次的生物生物学研究,使恶化率降低了54%。 The FDA approved GSK’s Exdensur, a twice-yearly biologic for severe asthma in patients 12+, reducing exacerbations by 54%.

美国食品和药物管理局(FDA)为12岁及12岁以上的患有重度哮喘的12岁病人批准了GSK的重度哮喘治疗(depemokimab),这标志着首次经批准每年两次使用剂量的生物治疗。 The U.S. FDA has approved GSK’s Exdensur (depemokimab) for severe asthma in patients aged 12 and older with an eosinophilic phenotype, marking the first biologic treatment approved for twice-yearly dosing. 该药物已经获得英国批准,在52周内将哮喘病恶化减少54%,并打算作为现有疗法的补充。 The drug, already approved in the UK, reduces asthma exacerbations by 54% over 52 weeks and is intended as an add-on to existing therapies. 虽然林业发展局拒绝批准慢性犀牛脑炎和鼻膜聚虫,但GSK计划从2025年12月开始在美国、欧盟、日本和中国执行监管决定,预计到2026年年中将获得批准。 While the FDA declined approval for chronic rhinosinusitis with nasal polyps, GSK plans to pursue regulatory decisions in the U.S., EU, Japan, and China starting December 2025, with approvals expected by mid-2026. 治疗耐受性良好, 旨在减少住院治疗和改善生活质量. The treatment is well-tolerated and aims to reduce hospitalizations and improve quality of life.